Fastest audit ever!
That was literally the fastest FDA Audit/Inspection "ever!" He arrived, in uniform, at 9:40am and left at 10:30am with no 483 observations. A very clean inspection! Michelle is invaluable.
Right the first time!
Talking with Michelle Lott, it was immediately clear establishing a new quality management system from scratch (with her) was the right way to go.
Highly collaborative!
lean RAQA is highly collaborative, which is precisely what you need for a strategy instead of a bunch of regulatory check boxes to fill in.
Without additional resources or effort!
By creating procedures and documentation around existing but previously undocumented processes, Michelle developed an easy-to-use, implement, and maintain system without additional resources or effort.
Confidence I was ‘doing everything right’
Michelle's Regulatory Pathway Assessment helped me get investment proposals, reliable cost estimates, and the confidence I was "doing everything right."
Knowledgeable, professional, and I enjoy her!
Michelle provided us with an excellent quality system plan. She’s knowledgeable, professional, and I enjoy her!
The Best Regulatory Affairs Consultant
Michelle is the best regulatory affairs consultant I have found in Arizona, maybe beyond. She is very experienced in drugs and medical devices and I’m confident she will provide great ideas to move your business forward.
Before Oprah came Michelle
Way before Oprah selected our gLOVE treat for her O List, and way before Paraffin quadrupled in size, there was – and still is – Michelle.
A “no shit” expert.
Michelle is a "no shit" expert in helping start-up companies with FDA. She sits on an FDA advisory committee, helped inform FDA's thinking on a classification, and has team members who specialize in a variety of medical devices.
Without hesitation.
Michelle’s regulatory strategy work gave us a competitive advantage. I recommend her without hesitation.
Expert on everything from labels to claims.
Michelle was very helpful on my PepsiCo project. So much so, I let my clients know I have an expert on everything from labels to claims on my team.
From zero to 60!
From zero to 60. Michelle is fast and good. In under two weeks, her due diligence helped us decide if an acquisition target’s RAQA issues should scuttle the deal. I heartily recommend her.
What a worthwhile investment!
We brought Michelle for full-day risk management training and got much more, including an insight on IVDR requirements that we used to terrific advantage! What a worthwhile investment that was!
Some kind of ‘Wonder Woman!’
Michelle is some kind of “Wonder Woman.” How else to describe her layered risk-management remediation plan that weathered three days, two audits, and two Notified Bodies. Love!
Top notch.
Michelle Lott is my absolute definite go-to for FDA consultation and regulatory support. In my experience so far, she is top notch.
Thank God for Michelle.
She kept our regulatory strategy on track despite our changing priorities, business goals, and management team!
